| January 24, 2012 |
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| News |
FDA Recommends Three Drug User Fee Programs
Susan Haigney
On Jan. 13, 2012, FDA announced it had completed, and transmitted to Congress, its recommendations for three user fee programs including the fifth authorization of the Prescription Drug User Fee Act and programs for human generic drugs and biosimilar biological products.
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AstraZeneca and IMS Health Announce Data and Research Collaboration
Amy Ritter
On Jan. 11, 2012, AstraZeneca and IMS Health announced a three-year collaboration to use real-world healthcare data from Europe to guide AstraZeneca’s discovery and clinical development programs.
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Push the Boundaries of Protein Analysis with Wide-Pore Sub-2 µm Columns
Achieve better protein analysis recovery, resolution, and scalability using new Agilent ZORBAX RRHD 300 Å 1.8 µm columns with expanded UHPLC capability to 1200 bar. StableBond technology in phases C18, C8 and C3 gives excellent stability, while unique 300Å diphenyl chemistry extends selectivity to the Diphenyl phase.
 More Information |
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Global Market Boom for Generic Drugs
Stephanie Sutton
The generic-drugs market is poised to experience strong growth as key blockbuster products go off patent, but companies looking to benefit from this will have to be careful about the product segments where they compete, according to a report from Frost & Sullivan.
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Bio-G Whitepaper: Quality by Design in Biomanufacturing
We invite you to download the latest Bio-G whitepaper: QbD in Biomanufacturing. QbD is increasingly required in our industry, but there are still gaps in understanding how QbD applies to the biomanufacturing process. This whitepaper looks at how biomanufacturing organizations can achieve continuous quality verification using real-time data. We focus on simple, practical examples of how top-tier biomanufacturers have implemented QbD.
In this whitepaper you will learn about:
- The role of QbD and ICH Q8-Q10 in improving both process development and manufacturing systems
- An analysis of toolsets and their role in 'seeing' variability and using it to informquality
- Practical approaches, such as statistical process control, and pitfalls associated with them
- More advanced data mining techniques and how they can assist QbD initiatives
Please register to download this Bio-G whitepaper at
 http://www.bio-g.com/whitepapers/download/quality-by-design-in-biomanufacturing |
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| Discovery Pipeline |
Amphotericin Primarily Kills Yeast by Simply Binding Ergosterol
Scientists from the University of Illinois show how amphotericin, an antifungal that has been prescribed for 50 years, really works. They found that creation of channels in the fungi was not required to kill fungal cells as had been long been thought. Instead, the critical step was the binding of the drug to a lipid molecule called ergosterol, found in fungi and yeasts. Understanding this mechanism provides a new avenue for the development of antifungals. (Proceedings of the National Academy of Sciences)
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Examination of Mesenchymal Stem Cell-Mediated RNAi Transfer to Huntington's Disease Affected Neuronal Cells for Reduction of Huntingtin
Mesenchymal stem cells are used as a delivery system for an RNA interference thereapy in a model of Huntington's disease. (Molecular and Cellular Neuroscience)
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EGFR and MET Receptor Tyrosine Kinase–Altered MicroRNA Expression Induces Tumorigenesis and Gefitinib Resistance in Lung Cancers
The most common form of lung cancer, non-small cell lung cancer, develops resistance to the drug gefitimib. Researchers from Ohio State University Medical Center found that upregulation of several micro RNAs contribute to gefitimib resistance, and suggest that screening patients based on levels of certain miRNAs may predict which will be responsive to gefitimib treatment. (Nature Medicine)
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Highly useful bioprocess information online
Introducing a new Biopharm International web site featuring practical tips and technical insights for the entire process development spectrum.
Check out these fresh new topics:
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| Company/People Notes |
| The CDMO Almac has opened a new £3-million ($4.6 million), 30,000-ft2 building at its Craigavon, United Kingdom, headquarters. The operations and departments at the new location will include packaging and distribution of medicinal supplies for clinical studies, business development, marketing, human resources, and information systems. Read More |
| In addition, Almac’s sciences business unit and the biopharmaceutical company MGB Biopharma have entered into a collaboration where Almac will manufacture the production of their lead gram positive antibacterial compound MGB-BP3. The compound is a DNA minor groove binder and is currently in preclinical development with IND filing targeted for the third quarter of 2012. Read More |
| Janssen Research & Development has opened Janssen Labs, a 30,000-ft2 life-sciences innovation center located within the company’s Janssen West Coast Research Center in San Diego, California. The expansion is designed to provide a capital efficient, flexible lab environment for start-up companies pursuing new technologies and research platforms to advance medical care. To date, the management team of Janssen Labs has received and reviewed more than 100 applications. Companies are evaluated based on criteria such as the scope of science and/or technology, area of significant medical or market need, credible science/technology team, demonstrated financial solvency, as well as several other areas. The applying companies represent the biotechnology, pharmaceutical, medical devices, instrumentation, and diagnostics sectors. The facility can accommodate a maximum of 18 to 20 companies, and the application and assessment process will continue throughout 2012. Read More |
| NantWorks, a technology company, has announced plans to locate a new pharmaceutical manufacturing plant in Terre Haute, Indiana. The company plans to invest $85.5 million to redevelop the former Pfizer facility in Terre Haute. The new manufacturing plant, which is expected to be operational in 2015, will produce critical-care injectable and oncological drugs. NantWorks was founded by Patrick Soon-Shiong, who previously developed two pharmaceutical companies: APP and Abraxis Biosciences. Read More |
| Novartis has announced plans to restructure its US general medicines business in the wake of the patent expiration of Diovan (valsartan), an antihypertensive drug, and the reduction in demand for the antihypertensive Rasilez/Tekturna (aliskiren) following the termination of a clinical study. The plans will result in the reduction of 1960 positions (1630 positions in its sales force and 330 support and headquartered positions). The restructuring is expected to result in an exceptional charge of approximately $160 million to be recognized in the results for the first quarter of 2012. The company hopes to produce full-year savings of approximately $450 million as of 2013, about half of which is expected to be realized in 2012 due to reorganization timelines. Read More |
| Takeda has announced plans to restructure following its October 2011 acquisition of Nycomed. The restructuring plans include a reduction of its global workforce by approximately 2800 (2100 in Europe and 700 in the US) positions by the end of fiscal year 2015 across the functions of R&D, commercial, operations, and general and administrative. Read More |
| In other news |
| Constellation Pharmaceuticals has formed an epigenetics drug-discovery and development collaboration with Genentech. |
| FEI has announced a collaboration with the National Institutes of Health to create a laboratory for structural biology research. |
| Genzyme has received EMA approval of its manufacturing plant in Framingham, Massachusetts, for the production of Fabrazyme (agalsidase beta). |
| Islet Sciences has selected NeoStem's manufacturing subsidiary Progenitor Cell Therapy for a product manufacturing agreement. |
| Paragon Bioservices received a multimillion-dollar US Department of Defense contract for filovirus vaccine development and manufacturing. |
| Quintiles has formed a new cancer biomarker R&D company. |
| SignaBlok has been awarded a US Department of Defense contract to support new technology to combat sepsis. |
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BioPharm Weekly Poll |
What is the most important change that has influenced chemical API manufacturing during the past 10 years? |
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Introducing a new series from BioPharm International, featuring biotech experts' commentary on moving products from discovery to development  View the series |
Biopharm International
The Magazine |
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Therapeutic Vaccine Outlook: Has an approval in oncology reignited interest in the recruitment of the immune system in the fight against disease?
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Coming soon!
BioPharm International's February 2012 issue features a case study focusing on biocontainment and facilities.
www.BiopharmInternational.com
| Marketplace |
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| Events |
January 30–31, 2012: Biomanufacturing Summit 2012
San Diego, CA
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January 30–February 1, 2012: Protein Therapeutics Forum 2012
Washington, DC
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January 30–February 1, 2012: Vaccine Forum
Washington, DC
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February 4–8, 2012: SLAS2012: The First Annual SLAS Conference and Exhibition
San Diego, CA
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March 19–22, 2012: 5th Annual BioPharma Asia Convention 2012
Singapore
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